2. Getting involved
3. Standards Committees
4. NAGESUTECH

DIN Standards Committee Health Technologies

Abstract

This part of ISO 11608 specifies the requirements and test methods for the design verification of containers and integrated fluid pathways for use with needle-based injection systems (NIS) that meet the specifications of ISO 11608-1. The containers covered by this standard include single-dose and multiple-dose containers (filled by the manufacturer or the end user) that can be provided to the end user already integrated into the NIS or for insertion into the NIS at the time of use. Excluded from the scope of application are - sterile hypodermic needles; - sterile hypodermic syringes; - sterile disposable syringes, with or without needle, for insulin; - Containers that can be refilled several times; - Containers for dental use; - Catheters or infusion sets that are attached or assembled separately by the user. This document was prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) and with the participation of German experts. The working committee NA 176-04-02 AA "Injection systems" in the Health Technologies Standards Committee (NAGesuTech) of the DIN German Institute for Standardization is responsible.

Begin

2025-07-18

WI

00205423

Planned document number

DIN EN ISO 11608-3/A1

Project number

17600174

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 84/WG 3 - Needle-based injection systems - Injector, container and pen needle  

draft standard

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (ISO 11608-3:2022/DAM 1:2025); German and English version EN ISO 11608-3:2022/prA1:2025
2025-11
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